Table 4.

Summary of related/possibly related AEs in the Western European study

Treatment	Number of subjects treated (N)	TEAE intensity	Number of times event occurred (e)	Number of subjects experiencing TEAE (n)	%
Placebo single dose	10	Mild	2	2	20
50 mg single dose	6	Mild	1	1	17
150 mg single dose	6	Mild	10	5	83
300 mg single dose	6	N/A
600 mg single dose	6	Mild	3	2	33
1000 mg single dose	6	Mild	1	1	17
Placebo multiple dose	8	Mild	1	1	13
10 mg multiple dose	6	N/A
50 mg multiple dose	6	Mild	3	1	17
150 mg multiple dose	6	Mild	3	3	50
450 mg multiple dose	6	Mild	1	1	17

N/A = not applicable; % = percentage of subjects who experienced the TEAE per treatment = (n/N) × 100.